pH value (+25°C): 7-8
Protein (Biuret): ≥65 mg/vial
Dilution: Up to 1:20 recommended
Solubility: Reconstitution of lyophilizate/vial in 1 mL water results in
serum typical solution
Typical concentrations determined by Roche cobas® assays:
Alpha fetoprotein (AFP): 2.0 IU/mL
Carcinoembryonic antigen (CEA): 1.3 ng/mL
Follicle stimulating hormone (FSH): 10.0 mIU/mL
Human chorionic gonadotropin (HCG): 2.8 mIU/mL
Luteinizing hormone (LH): 8.1 mIU/mL
Prolactin: 160.7 μIU/mL
Prostate specific antigen (PSA): 0.3 ng/mL
PSA free: 0.06 ng/mL
Thyroid stimulating homone (TSH): 2.5 μIU/mL
Troponin T (TN-T): Not detectable Appearance: Yellowish lyophilizate
Interference effect: Corresponds to specification
Infectious parameters (determined by FDA approved methods):
Non reactive HbsAg: Corresponds to specification
Anti HIV 1+2: Negative
Anti HCV: Negative
HIV 1 NAT, non reactive: Corresponds to specification
Stability: At -15 to – 25°C within specification range for 24 months